Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
Symptomatic treatment of pain and inflammation in rheumatoid arthritis (including systemic Juvenile Idiopathic Arthritis [sJIA]), osteoarthritis, seronegative arthropathies and in painful swelling and inflammation after soft tissue injuries.
The treatment should start with the lowest dose anticipated to be effective, which can subsequently be adjusted, depending on the therapeutic response and any undesirable effects. In long-term treatment a low maintenance dose should be the aim.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
One 600 mg tablet three times daily. An interval of at least 4-6 hours should be allowed between doses. Some patients can be maintained on 600-1200mg daily. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400mg in divided doses. This tablet cannot be halved and in some instances a different strength or formulation of ibuprofen must be used.
Adolescents over 12 years of age (>40 kg): The recommended dose is 20-30mg/kg body weight daily in 3 to 4 divided doses up to a maximum of 40 mg/kg body weight daily in severe cases. Ibuprofen 600mg tablet is not suitable for children and adolescents younger than 12 years of age as correct dosing is not possible.
The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic function is impaired, dosage should be assessed individually.
Caution should be taken with ibuprofen dosage in patients with renal impairment. The dosage should be assessed individually. The dose should be kept as low as possible and renal function should be monitored (see sections 4.3, 4.4 and 5.2).
Caution should be taken with dosage in patients with hepatic impairment. The dosage should be assessed individually and the dose should be kept as low as possible (see sections 4.3, 4.4 and 5.2).
For oral use.
It is recommended that patients with sensitive stomachs take ibuprofen tablet with food. If taken shortly after eating, the onset of action of ibuprofen tablet may be delayed. To be taken preferably with or after food, with plenty of fluid. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.
Risk of symptoms at doses >80–100 mg/kg. At doses >200 mg/kg there is a risk of severe symptoms, though with considerable variations between individuals. A dose of 560 mg/kg in a child aged 15 months gave severe intoxication, 3.2 g in a 6-year-old mild to moderate intoxication, 2.8–4 g in a 1½-year-old and 6 g in a 6-year-old severe intoxication even after gastric lavage, 8 g in an adult moderate intoxication and >20 g in an adult very severe intoxication. 8 g administered to a 16-year-old affected the kidney and 12 g in combination with alcohol administered to a teenager resulted in acute tubular necrosis.
Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours.
The predominant symptoms of overdose are ones from the gastrointestinal tract, e.g. nausea, abdominal pain and vomiting (possibly blood-streaked). Central nervous system effects include headache, tinnitus, confusion and nystagmus. At high doses loss of consciousness and convulsions (mainly in children) may occur. Cardiovascular toxicity, including bradycardia, tachycardia and hypotension have been reported. Hypernatraemia, kidney effects and haematuria may occur. In serious poisoning metabolic acidosis may occur. In significant overdose, renal failure and liver damage are possible. Hypothermia and ARDS have occasionally been reported.
Management should be symptomatic and supportive as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
In the event of gastrointestinal problems, administer antacids. In the event of hypotension, intravenous fluid and, if required, inotropic support. Ensure adequate diuresis. Correct acid-base and electrolyte disorders.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
5 years.
This medicinal product does not require any special storage conditions.
PVC – Aluminium blisters or PVC/PVdC – Aluminium Blisters
Pack sizes: 10, 14, 21, 28, 30, 40, 42, 50, 60, 84, 100 or 500 film-coated tablets in carton.
Not all pack sizes may be marketed.
No special requirements.
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